GSK fined over vaccine trials; 14 babies reported dead

GSK fined over vaccine trials; 14 babies reported dead

Tuesday, January 3, 2012

By Javier Cardenal Taján

BuenosAiresHerald.com staff

GlaxoSmithKline Argentina Laboratories Company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for irregularities during lab vaccine trials conducted between 2007 and 2008 that allegedly killed 14 babies.

Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined 300,000 pesos each for irregularities during the studies.

The charges included experimenting with human beings as well falsifying parental authorizations so babies could participate in the vaccine-trials conducted by the laboratory from 2007 to 2008.

Since 2007, 15,000 children, under the age of one, from Mendoza, San Juan and Santiago del Estero provinces have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals fro medical treatment.

A total of seven babies died in Santiago del Estero; five in Mendoza; and two in San Juan.

Pediatrician Ana Marchese, who reported the case to the Argentine Federation of Health Professionals (FESPROSA in Spanish), and was working at the Eva Perón children's public hospital in Santiago del Estero by the time the studies were being conducted, said this morning in conversations with Continental AM radio that “GSK Argentina set a protocol at the hospital, and recruited several doctors working there.”

“These doctors took advantage of the many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”

“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries."

Colombia and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.

Likewise, Marchese, explained the modus operandi: “Once a picked patient arrives, it would automatically disappear to be taken somewhere else in order to be treated by those doctors specially recruited by GSK. These sorts of practices are not legal and occurred without any type of state control, plus they don’t comply with the minimum ethical requirements.”

Marchese also remembered that “laboratory trials on human beings are not legalized in Argentina.”

Furthermore, the pediatrician revealed that “in various particular cases, the doctors who had conducted the trials avoided to answer the many phone calls made by worried parents after witnessing their babies’ first reactions to the vaccines.”

According to Marchese, “there already exist very good vaccines for the same diseases, but we all know how laboratories work, they only care for their own business.”

To end, Doctor Marchese aimed to Santiago del Estero Governor, Gerardo Zamora, who “never came out to stage to comment on the case, and the same happened with national deputies and senators that didn’t even bother into discussing a hot topic like this, not even after it being echoed worldwide. I’m also ashamed of the scientific community that also kept its mouth shut.”

Julieta Ovejero, great aunt of one of the six babies who died in Santiago del Estero, told reporters that “A lot of people wanted to leave the protocol but they were not allowed; they forced them to continue under the threat that if they leave they wouldn’t get any other vaccines for their children.”

During 2008, the vaccine trial was still ongoing despite the reports issued by FESPROSA, and those in charge of the study told reporters that the procedures were being carried out in a lawful manner.

On the contrary, the ruling states that the laboratory as well the involved doctors broke all legal requirements for conducting clinical tests on babies.

Surprisingly, during same year pediatrician Enrique Smith, one of the lead investigators told reporters: “Only 12 people have died throughout the country, which is a very low figure if we compare it with the deaths produced by the respiratory illnesses that the pneumococcal bacteria causes.”

In Santiago del Estero, one of the country's poorest provinces, the trials were authorized when Enrique's brother, Juan Carlos Smith, was the provincial health minister.

According to Fesprosa, “the laboratory paid 8,000 pesos for each child included in the study, but none (of that money) remained in the province that lent its public facilities and the health personnel to conduct the private research.”

Meanwhile, a press communiqué was released by the ANMAT indicating that the irregularities detected during the COMPASS vaccine trial program were related to “failures in the process of obtaining the necessary consent letters from participants, hence violating the patients' rights; as well the inclusion of patients that did not fully meet the required clinical conditions to be submitted into the program.”

Furthermore, the release states that “We [ANMAT] expressly remark that none of the deaths mentioned in the media were related to the vaccines given as part of the COMPASS program, since all the involved patients received what is called a blind placebo, which is a simile of the vaccine but without any active substance. The vaccine is safe.”

GlaxoSmithKline is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom. It is the world's third-largest pharmaceutical company measured by revenues after Johnson & Johnson and Pfizer.

Ironically, if one visits GlaxoSmithKline Argentina web site it welcomes the reader with a company disclosure that says: “We have a challenging and inspiring mission to improve the quality of human life by enabling people to do more, feel better and live longer."

According to www.GSK.com site, Glaxo was originally a baby food manufacturer processing local milk into a baby food by the same name, and founded in Bunnythorpe, New Zealand in 1904. The product was sold in the 1930s under the slogan "Glaxo builds bonny babies".

GlaxoSmithKline Argentina’s massive 28,333 square-metre manufacturing plant is located in Northern Greater Buenos Aires town of San Fernando.